By Counterforce Health Team in Krystexxa (pegloticase) —

Do You Qualify for Krystexxa Coverage by Blue Cross Blue Shield in Pennsylvania? Decision Tree & Next Steps

Answer Box: Quick Qualification Check

Getting Krystexxa (pegloticase) covered by Blue Cross Blue Shield in Pennsylvania requires: (1) chronic gout refractory to allopurinol/febuxostat at maximum doses for ≥3 months with serum uric acid >6 mg/dL, (2) ≥2 flares in past 12 months or tophi present, and (3) negative G6PD test. First step: Contact your rheumatologist to document prior therapy failures and submit prior authorization through Highmark's Provider Resource Center or your specific Blue plan's portal. If denied, Pennsylvania's new Independent External Review Program has a 53% overturn rate.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible" - Document Checklist
  4. If "Possibly Eligible" - Tests & Timeline
  5. If "Not Yet" - Alternatives & Exceptions
  6. If Denied - Appeal Path Chooser
  7. Coverage at a Glance
  8. Common Denial Reasons & Fixes
  9. FAQ

How to Use This Guide

This decision tree helps you determine if you qualify for Krystexxa (pegloticase) coverage through Blue Cross Blue Shield plans in Pennsylvania. Start with the eligibility triage below, then follow the recommended path based on your results.

Note: Blue Cross Blue Shield operates through independent regional plans. In Pennsylvania, you're likely covered by Highmark Blue Shield (western PA) or Independence Blue Cross (southeastern PA). Requirements may vary slightly between plans.

Eligibility Triage: Do You Qualify?

Work through these questions with your healthcare provider:

✅ Likely Eligible if ALL apply:

  • Age ≥18 years with chronic gout diagnosis
  • Failed allopurinol ≥300mg daily for ≥3 months (or contraindicated due to hypersensitivity/HLA-B*5801)
  • Failed febuxostat 80-120mg daily for ≥3 months (or contraindicated)
  • Serum uric acid persistently >6 mg/dL despite maximum XOI therapy
  • ≥2 gout flares in past 12 months OR ≥1 subcutaneous tophus OR chronic gouty arthropathy
  • G6PD deficiency test negative
  • Prescribed by rheumatologist or nephrologist

⚠️ Possibly Eligible if some apply:

  • Have chronic gout but haven't tried maximum doses of both allopurinol AND febuxostat
  • Serum uric acid >6 mg/dL but only 1-2 months on current XOI therapy
  • Frequent flares but <2 in past 12 months documented
  • Haven't been tested for G6PD deficiency
  • Primary care provider willing to refer to rheumatology

❌ Not Yet Eligible if:

  • Asymptomatic hyperuricemia only (no gout attacks)
  • Haven't tried first-line XOI therapy (allopurinol or febuxostat)
  • G6PD deficiency present
  • Serum uric acid <6 mg/dL on current therapy
  • No documented gout flares or tophi

If "Likely Eligible" - Document Checklist

Required Documentation for Prior Authorization:

Clinical History:

  • Chronic gout diagnosis with ICD-10 code (M1A.9 for chronic gout, unspecified)
  • Documentation of ≥2 flares in past 12 months OR presence of tophi OR gouty arthropathy
  • Chart notes showing persistent symptoms despite treatment

Laboratory Results:

  • G6PD enzyme activity test (normal/negative result required)
  • Serial serum uric acid levels >6 mg/dL over ≥3 months
  • Recent comprehensive metabolic panel

Prior Therapy Documentation:

  • Allopurinol trial: dose, duration (≥3 months), outcome, reason for discontinuation
  • Febuxostat trial: dose, duration (≥3 months), outcome, reason for discontinuation
  • Any uricosuric therapy trials (probenecid) if applicable

Submission Path:

  1. Highmark Blue Shield (Western PA): Submit through Provider Resource Center portal
  2. Independence Blue Cross (Eastern PA): Use provider portal or call provider services
  3. Other PA Blues: Contact member services for specific submission requirements
Tip: Most Blue plans require submission 5-7 business days before planned treatment start date.

If "Possibly Eligible" - Tests & Timeline

Missing Requirements to Address:

Need G6PD Testing:

  • Order G6PD enzyme activity test (not genetic testing)
  • Results typically available within 2-3 business days
  • Required due to FDA contraindication for G6PD deficiency

Need XOI Optimization:

  • Allopurinol: titrate to maximum tolerated dose (typically 300-800mg daily based on kidney function)
  • Febuxostat: try 80mg daily, increase to 120mg if needed
  • Document ≥3 months at maximum appropriate dose with persistent SUA >6 mg/dL

Need Specialist Referral:

  • Request rheumatology consultation
  • Bring gout flare history, medication trials, and lab results
  • Rheumatologist documentation strengthens prior authorization

Timeline to Re-apply:

  • G6PD testing only: 1-2 weeks
  • XOI optimization: 3-4 months minimum
  • Specialist consultation: 2-8 weeks (varies by availability)

If "Not Yet" - Alternatives & Exceptions

First-Line Alternatives to Discuss:

  • Allopurinol optimization: Start 100mg daily, titrate based on SUA and kidney function
  • Febuxostat: Alternative XOI, especially if allopurinol contraindicated
  • Probenecid: Uricosuric agent (avoid if kidney stones present)
  • Lifestyle modifications: Dietary changes, weight management, alcohol reduction

Exception Request Strategy:

If standard criteria aren't met but clinical need is compelling:

  1. Document unusual circumstances: Severe tophi, joint damage, occupational impact
  2. Highlight contraindications: HLA-B*5801 positive (allopurinol hypersensitivity risk)
  3. Emphasize urgency: Progressive joint destruction, recurrent hospitalizations

When navigating complex prior authorization requirements, Counterforce Health helps patients and providers turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific rules.

If Denied - Appeal Path Chooser

Pennsylvania's Three-Level Process:

Level 1: Internal Appeal (Required First Step)

  • Timeline: Submit within 180 days of denial notice
  • Decision deadline: 30 days for standard, 72 hours for urgent
  • How to submit: Blue plan member portal, phone, or written request
  • Required: Copy of denial letter, supporting clinical documentation

Level 2: Peer-to-Peer Review

  • When: If Level 1 denied, request physician-to-physician discussion
  • Timeline: Usually 1-3 business days to schedule
  • Participants: Your prescribing physician and plan medical director
  • Preparation: Review denial rationale, prepare clinical justification

Level 3: Pennsylvania Independent External Review

  • Eligibility: Must complete internal appeals first
  • Timeline: Submit within 4 months of Final Adverse Benefit Determination
  • Success rate: 53% overturn rate in 2024
  • Cost: Free to consumers
  • Submit: Pennsylvania Insurance Department website
Pennsylvania Advantage: The state's new Independent External Review Program launched in 2024 has helped over 250 patients successfully appeal denied treatments, with most decisions issued within 60 days.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Blue plans Highmark Provider Resources
Diagnosis Chronic gout (ICD-10: M1A.9) Medical record documentation
Prior Therapy Failed allopurinol + febuxostat ≥3 months each Pharmacy records, chart notes
Lab Requirements G6PD negative, SUA >6 mg/dL Recent lab results
Prescriber Rheumatologist preferred Provider NPI verification
Billing Code J2507 (8 units per dose) Krystexxa Billing Guide
Appeal Deadline 180 days internal, 4 months external Denial letter, PA law

Common Denial Reasons & Fixes

Denial Reason How to Overturn
"Not refractory to conventional therapy" Submit detailed pharmacy records showing maximum dose trials ≥3 months with persistent SUA >6 mg/dL
"Missing G6PD test" Order G6PD enzyme activity test; submit results showing normal activity
"Prescriber not specialist" Request rheumatology consultation or have PCP submit with specialist co-signature
"Insufficient documentation of flares" Provide emergency room records, urgent care visits, or detailed symptom diary
"Serum uric acid not consistently elevated" Submit serial lab results over 3-6 months showing persistent elevation >6 mg/dL
"Not medically necessary" Include FDA label excerpts, ACR gout guidelines, and tophi measurements/photos

FAQ

How long does Blue Cross Blue Shield prior authorization take in Pennsylvania? Standard PA decisions are issued within 14 days of complete submission. Urgent requests are processed within 72 hours. Incomplete submissions may delay the timeline.

What if Krystexxa is non-formulary on my plan? Request a formulary exception with your prior authorization. Include clinical rationale for why formulary alternatives (allopurinol, febuxostat) are inappropriate or ineffective.

Can I request an expedited appeal in Pennsylvania? Yes, if your condition poses an imminent threat to your health. Submit clinical documentation supporting urgency. Expedited appeals are decided within 72 hours.

Does step therapy apply if I failed XOI therapy outside Pennsylvania? Yes, pharmacy records from any state showing documented failure of allopurinol and febuxostat should satisfy step therapy requirements. Ensure records clearly show doses and duration.

How much does Krystexxa cost without insurance? Approximately $30,000 per infusion (every 2 weeks), with annual costs potentially reaching $780,000. Patient assistance programs may be available through Amgen By Your Side.

What happens if Pennsylvania's external review overturns my denial? The insurer must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal process.

Sources & Further Reading

For complex cases requiring detailed appeals strategy, Counterforce Health specializes in turning insurance denials into successful approvals by crafting evidence-backed appeals tailored to each payer's specific requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for personalized guidance. Coverage policies may change; verify current requirements with your specific Blue Cross Blue Shield plan.

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